ECZEMA DERMATITIS RELIEF BALM
- Product NDC
- 61328-112
- 11-digit product format
- 613280112
- Labeler code
- 61328
- Product ID
- 61328-112_5b4ad054-9ed9-c5f3-e063-6294a90a0d33
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- COLLOIDAL OATMEAL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Skinfix, Inc.
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-01
- Substance
- OATMEAL
- Active strength
- 5 g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ECZEMA DERMATITIS RELIEF BALM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OATMEAL | 5 g/100g |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 124351b2-6dbf-42d0-9ea7-f0e299215f9a | Product name | 1 | 20210115 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61328-112-20 | ECZEMA DERMATITIS RELIEF BALM | 50 g in 1 BOTTLE, PUMP | CREAM | 50 | 4 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| EIGHT HOUR SKIN FRAGRANCE FREE | PETROLATUM | REVLON | b61d6e2e-18dd-37d2-e053-2a95a90af57b | 2025-08-01 | Warnings | M016 |
| Vigority Wild Yam Cream | ESTRIOL CREAM | FOUNDATION COMMERCE INC | 39b2bef7-46c5-9ad5-e063-6294a90ae983 | 2025-07-30 | Warnings | M016 |
| Rugby Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Rugby Laboratories | 9af3a740-ef97-26ce-e053-2a95a90a0ee1 | 2025-07-28 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | e7eb10b7-3950-49cb-ba73-11e7581b6be9 | 2025-07-25 | Warnings | M016 |
| ProCure SkinGuard | PETROLATUM 49.9% | Twin Med LLC | 3a1721f6-1bb0-cd47-e063-6394a90a148e | 2025-07-25 | Warnings | M016 |
| ProCure HydroCerin | PETROLATUM 33% | Twin Med LLC | 3ab7248d-b914-9fdd-e063-6294a90ac4c8 | 2025-07-24 | Warnings | M016 |
| AD PREVENT Original | AD PREVENT ORIGINAL | WellSpring Pharmaceutical Corporation | cf73246e-81c1-42e9-a107-dc6c99cf7d01 | 2025-07-24 | Warnings | M016 |
| Dimethicone 1 Skin Protectant | DIMETHICONE | Universal Distribution Center LLC | 2c5b96b9-24d6-4223-a63d-fe83d7c02368 | 2025-07-24 | Warnings | M016 |
| Dr Butlers Soothing Incontinence | MINERAL OIL 59.8%, PETROLATUM 36.0% | Beyond Health PA | 3a9d3796-fd05-fe57-e063-6294a90a0ac6 | 2025-07-23 | Warnings | M016 |
| A and D plus E | VITAMIN A, D AND E OINTMENT | Derma Sciences Canada Inc. | 35aca592-bfd0-652f-e063-6394a90ac53e | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Derma Sciences Canada Inc. | 3a895e6c-da8d-db9b-e063-6394a90ace40 | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLEUM JELLY | NeilMed Pharmaceuticals Inc. | 36bbbb1e-78e9-98f6-e063-6294a90a66d1 | 2025-07-21 | Warnings | M016 |
| Mountain Ice Eczema | COLLOIDAL OATMEAL | Mountainside Medical Equipment, Inc. | 1a91f33e-dd85-4d5a-b61c-e460a507e292 | 2025-07-21 | Warnings | M016 |
| Our Eczema Remedy | COLLOIDAL OATMEAL | Fewer Better Things | 3a755b4c-47c8-9ca5-e063-6394a90af84a | 2025-07-21 | Warnings | M016 |
| Aveeno DAILY MOISTURIZING | DIMETHICONE | Kenvue Brands LLC | 54a13b85-32b5-439d-a27a-8fba2cf44251 | 2025-07-16 | Warnings | M016 |
| ProCure Moisture Barrier | 1% DIMETHICONE, 12% ZINC OXIDE | Twin Med LLC | 3988c83b-d4eb-1f09-e063-6394a90a45ad | 2025-07-14 | Warnings | M016 |
| Avalon Organics Antidandruff Conditioner | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66db1071-022a-aa19-e053-2a91aa0a8e39 | 2025-07-11 | Warnings | M016 |
| Avalon Organics Antidandruff | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66c7f730-64f3-4eef-e053-2a91aa0a4225 | 2025-07-11 | Warnings | M016 |
| terrasil Infection Protection Wound Care Maximum Strength | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7 | 2025-07-11 | Warnings | M016 |
| terrasil Skin Repair | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 92a23c7f-6b89-49cb-93e2-49ab7a85c86d | 2025-07-11 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1595494 | colloidal oatmeal 5 % Topical Cream | PSN | fb801d20-9bec-1c71-e053-6394a90a6e95 | 4 |
| 1595494 | colloidal oatmeal 50 MG/ML Topical Cream | SCD | fb801d20-9bec-1c71-e053-6394a90a6e95 | 4 |
| 1595494 | colloidal oatmeal 5 % Topical Cream | SY | fb801d20-9bec-1c71-e053-6394a90a6e95 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61328-112-20 | 61328011220 | 50 g in 1 BOTTLE, PUMP (61328-112-20) | 50 g | 2023-10-01 | No | No | Current |
| 61328-112-30 | 61328011230 | 1 TUBE in 1 CARTON (61328-112-30) / 40 g in 1 TUBE | 1 tube | 2026-09-12 | No | No | Current |